Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17 de junio de 2026 actualizado por: Hospital Clinic of Barcelona
Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women
This study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest.
This is a specifically designed physical activiity program, consisting of a resistance and strength exercises intended to be performed even while in bed and seeks to address physical and emotional health challenges during hospitalization.
The study will compare outcomes between participants who follow the exercise program and those receiving standard care.
Primary outcomes include physical and emotional health parameters, quality of life, and sleep quality.
Secondary outcomes focus on feasibility, adherence, and participant satisfaction.
This research addresses the gap in physical activity guidelines for pregnant individuals on bed rest and explores the potential benefits of exercise to improve maternal well-being and postpartum recovery.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
This study investigates the feasibility and potential benefits of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. The program includes resistance and strength exercises tailored to be safely performed while in bed, aiming to counteract the physiological and psychological deconditioning associated with prolonged inactivity during hospitalization.
Prolonged bed rest during pregnancy, often prescribed for high-risk conditions, can result in muscle atrophy, reduced cardiovascular capacity, and psychological distress, including anxiety, stress, and depression. Despite the known adverse effects of inactivity, there is limited evidence on structured exercise programs for this population. This study seeks to fill that gap by testing an intervention designed to mitigate these negative outcomes.
Participants will be randomized into two groups: an exercise group (EG) and a no-exercise group (NEG). The EG will perform daily supervised exercises, lasting approximately 30 minutes, under the guidance of trained staff. The NEG will follow standard care without structured physical activity. The study evaluates physical health parameters (e.g., activity levels, muscle strength), mental health outcomes (e.g., anxiety, depression, stress), sleep quality, and quality of life. Secondary objectives include assessing program feasibility, recruitment rates, adherence, and participant satisfaction.
Data collection will include validated self-reported questionnaires, wearable devices (accelerometers), and clinical measures. Key endpoints will be compared between groups at regular intervals during hospitalization and at six weeks postpartum.
This pilot randomized controlled trial aims to generate knowledge on the acceptability, safety, and preliminary effectiveness of bed-rest exercise programs in high-risk pregnancies, with the goal of informing future larger-scale studies and addressing an unmet need in maternal care.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
140
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Montse Palacio, MD, PhD
- Número de teléfono: 9946 +34932275400
- Correo electrónico: secmmf@clinic.cat
Copia de seguridad de contactos de estudio
- Nombre: Federico Migliorelli, Migliorelli, MD, PhD
- Número de teléfono: 9946 +34932275400
- Correo electrónico: secmmf@clinic.cat
Ubicaciones de estudio
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Barcelona
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Barcelona, Barcelona, España, 08028
- Hospital Clinic de Barcelona
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Contacto:
- Montse Palacio, MD, PhD
- Número de teléfono: 9946 +34932275400
- Correo electrónico: secmmf@clinic.cat
-
Contacto:
- Federico Migliorelli, MD, PhD
- Número de teléfono: 9946 +34932275400
- Correo electrónico: secmmf@clinic.cat
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Maternal age of 18 or more
- Delivery not expected within 1 week after recruitment.
- Language ability to understand the study.
- Informed consent signed.
Exclusion Criteria:
- Fetal death
- Severe mental health disorders and substance abuse disorders.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication and will receiving the intervention and monitored according to study procedures
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Programa de ejercicios específicamente diseñado y estructurado (basado en resistencia/fuerza, diseñado para ser ejecutado en cama o con mínima movilidad).
Es una adaptación del programa de ejercicios descrito por Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Ejercicio en reposo en cama, restricción de actividades y embarazos de alto riesgo: un estudio de viabilidad.
Fisiología Aplicada, Nutrición y Metabolismo.
2011;36(4):577-582).
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Sin intervención: Non-exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication without any specific instructions to engage in physical activity, also monitored according to study procedures.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluación de viabilidad de la implementación del programa de ejercicios: tiempo necesario para reclutar el tamaño de la muestra
Periodo de tiempo: Hasta la finalización del estudio, un promedio de 6 meses.
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Tiempo necesario para reclutar el tamaño de la muestra (en días)
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Hasta la finalización del estudio, un promedio de 6 meses.
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Evaluación de viabilidad de la implementación del programa de ejercicios: Número de mujeres que rechazaron participar en el estudio.
Periodo de tiempo: Hasta la finalización del estudio, un promedio de 6 meses.
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Número de mujeres que rechazaron participar en el estudio.
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Hasta la finalización del estudio, un promedio de 6 meses.
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Evaluación de viabilidad de la implementación del programa de ejercicios: Número de mujeres que renuncian a participar en el estudio.
Periodo de tiempo: Hasta la finalización del estudio, un promedio de 6 meses.
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Número de mujeres que renuncian a participar en el estudio.
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Hasta la finalización del estudio, un promedio de 6 meses.
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Evaluación de viabilidad de la implementación del programa de ejercicios: Adhesión al programa.
Periodo de tiempo: Hasta la finalización del estudio, un promedio de 6 meses.
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Adherencia al programa (número de días de realización real del programa de ejercicios durante el ingreso)
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Hasta la finalización del estudio, un promedio de 6 meses.
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Evaluación de satisfacción
Periodo de tiempo: En la entrega
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Un cuestionario elaborado específicamente para el caso que evalúa diferentes dominios (duración de las sesiones, dureza de las sesiones, repetición diaria de las sesiones, dificultad en ejercicios particulares, voluntad de repetir en caso de reingreso, satisfacción general de ser incluido en el programa). ) - Escala Likert (de 1 a 5, siendo 1 nada satisfecho y 5 muy satisfecho).
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En la entrega
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Physiological parameters: Rectus femoris area measurement
Periodo de tiempo: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound
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Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Physiological parameters: Time spent in moderate or vigorous activity
Periodo de tiempo: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Time spent in moderate or vigorous activity (in minutes, summarized as average per day).
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Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Physiological parameters: Total physical activity
Periodo de tiempo: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Total physical activity (average per day in mG).
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Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Physiological parameters: Handgrip strength test.
Periodo de tiempo: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Handgrip strength test (in kg, adjusted for gender and age).
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Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Mental health/emotional parameters: GAD-7
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21).
The higher the results, higher is the severity of anxiety.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Mental health/emotional parameters: Perceived Stress Scale (PSS-10)
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Perceived Stress Scale (PSS-10) (score ranging from 0 to 40).
The higher the results, higher is the perception of stress.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Mental health/emotional parameters: Edinburg Postpartum Depression Scale
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Edinburg Postpartum Depression Scale (EPDS) (score -ranging from 0 to 30- and percentage of score ≥9).
The higher the total score, more intense is the emotional stress.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Sleep cycle and Quality of life parameters: Sleep average per night
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
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Sleep average per night (in minutes)
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
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Sleep cycle and Quality of life parameters: WHOQOL-BREF score
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
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Abbreviated version of the World Health Organization Quality of Life Assessment scale (WHOQOL-BREF) (score ranging from 0 to 100).
The higher the score, better is the perception of quality of life.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
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Mental health/emotional parameters: SAM: The Self-Assessment Manikin
Periodo de tiempo: Daily
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Visual standardized measure of emotional tone that covers 3 different affective domains (valence, arousal and sense of control).
Responses are made by selecting the manikin that best represents the emotional state of the patient.
The patient selection is afterwards converted into a numerical result with higher scores indicating more positive affective tone.
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Daily
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Mental health/emotional parameters: RRS: The Ruminative Response Scale
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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10-item questionnaire intended to measure rumination, tendency to worriedness and repetitive thinking in front of stressful situations.
(score ranking from 10 to 40).
Higher scores indicate a higher tendeny to ruminate and a vulnerability trait to psychological distress
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Mental health/emotional parameters: BDI-II:
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Questionnaire to measuring depression at a cognitive, affective and behavioral level.
For the present study only 4 items related to hedonic experience will be selected.
Higher scores in each item indicate severity in the loss of hedonic capacity.
Reponses are made by using a 4-point Likert scale.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Physiological parameters: Muscle Ultrasound
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Muscle ultrasound will be conducted weekly by blinded sonographers using a linear probe (7.5 - 10 MHz).
All images will be acquired in triplicate, and the average value will be used for analysis.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Physiological parameters: Maternal Cardiac Ultrasound
Periodo de tiempo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Transthoracic echocardiography will be performed using standardised imaging protocols.
All measurements will be performed in triplicate when feasible, and averaged for analysis.
Standardization of acquisition settings and operator blinding to clinical data will be ensured to reduce measurement bias.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Periodo de tiempo: Baseline
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The questionnarie self-clasisfies how often and for how long the participant engages in light-, moderate-, or vigorous-intensity physical activity.
It also assesses whether the participant should consult her obstetric health care provider before beginning or continuing physical activity during pregnancy.
The GAQP is a screening and classification tool and does not generate a numerical summary score.
Therefore, no minimun or maximum applies, and higher or lower scores do not indicate a better or worse outcome.
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Baseline
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Baseline Maternal and fetal characteristics: Maternal age
Periodo de tiempo: Baseline
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Maternal age (In years)
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Baseline
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Baseline Maternal and fetal characteristics: Maternal weight
Periodo de tiempo: Baseline
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Maternal weight (In kg)
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Baseline
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Baseline Maternal and fetal characteristics: Ethnic group
Periodo de tiempo: Baseline
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Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian
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Baseline
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Baseline Maternal and fetal characteristics: Gestational age at recruitment
Periodo de tiempo: Baseline
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Gestational age at recruitment (in weeks + days)
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Baseline
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Baseline Maternal and fetal characteristics: Twin pregnancy
Periodo de tiempo: Baseline
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Twin pregnancy (yes/no)
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Baseline
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Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Periodo de tiempo: Baseline
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Fetal growth percentile at admission (customized for gender and multiplicity)
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Baseline
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Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
Periodo de tiempo: Baseline
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Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
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Baseline
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Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Periodo de tiempo: Baseline
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Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
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Baseline
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Maternal and fetal characteristics during hospital admission: Medication while admitted
Periodo de tiempo: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)
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Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit
Periodo de tiempo: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Length of stay in the intermediate care unit (in days)
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Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Maternal and fetal characteristics during hospital admission: Length of hospital admission
Periodo de tiempo: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Length of hospital admission (in days)
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Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Maternal and fetal characteristics during hospital admission: Fetal CTG
Periodo de tiempo: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Fetal CTG description
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Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Maternal and fetal characteristics during hospital admission: Diet during the admission
Periodo de tiempo: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Diet during the admission (in Kcal and special needs)
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Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Maternal and fetal characteristics during hospital admission: Daily fluid intake
Periodo de tiempo: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Daily fluid intake (in mL)
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Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Gestational age at delivery
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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Gestational age at delivery (in weeks + days
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Birthweight
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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Birthweight (in grams) and percentile
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: SGA/growth restriction
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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SGA/growth restriction (yes/no) and classification, if any
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Mode of delivery
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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Mode of delivery (spontaneous, assisted, cesarean section)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Composite adverse maternal outcome
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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Composite adverse maternal outcome (yes/no considering any of the following: re-intervention, endometritis, infection of surgical wound, curettage, admission to intensive care unit, hysterectomy, need for transfusion, postpartum hemorrhage requiring medication other than oxytocin or ergometrine, maternal sepsis, death)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Neonatal admission to neonatal intensive care unit
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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Neonatal admission to neonatal intensive care unit (yes/no)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Composite adverse neonatal outcome
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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Composite adverse neonatal outcome: (yes/no considering any of the following: respiratory morbidity - respiratory distress syndrome or transient tachypnea - requiring intubation, moderate-severe bronchopulmonary dysplasia, intraventricular hemorrhage grade III-IV, early-onset sepsis, periventricular leukomalacia, necrotizing enterocolitis, retinopathy requiring laser, fetal or neonatal death)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Breastfeeding rates
Periodo de tiempo: Whitin 24h after delivery and 6 weeks postpartum
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Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2029
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
18 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BedRest Pregnancy Study
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data (IPD) will not be shared with esteranl researchers.
Study finding will be reported in peer-reviewed scientific journals and presented at scientific meetings in aggregate form, without disclosure of identifiable participant information.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .